ES2663817T3 - Process to produce a stable injectable solution of noradrenaline at low concentration - Google Patents
Process to produce a stable injectable solution of noradrenaline at low concentration Download PDFInfo
- Publication number
- ES2663817T3 ES2663817T3 ES15712064.3T ES15712064T ES2663817T3 ES 2663817 T3 ES2663817 T3 ES 2663817T3 ES 15712064 T ES15712064 T ES 15712064T ES 2663817 T3 ES2663817 T3 ES 2663817T3
- Authority
- ES
- Spain
- Prior art keywords
- norepinephrine
- solution
- noradrenaline
- produce
- injectable solution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Un proceso para producir una disolución inyectable estable que contiene noradrenalina de 0,04 a 0,20 mg/ml, que se caracteriza porque incluye las siguientes etapas: a. disolver la noradrenalina y opcionalmente un excipiente en agua desoxigenada o desgasificada para obtener una concentración de noradrenalina de 0,04 a 0,20 mg/ml, b. ajustar el pH de la disolución resultante añadiendo ácido clorhídrico hasta alcanzar un valor en el intervalo de 3,2 a 3,6, c. filtrar la disolución de noradrenalina resultante en una corriente de gas inerte, d. distribuir la disolución de noradrenalina en una corriente de un gas inerte, e. esterilizar la disolución de noradrenalina.A process for producing a stable injectable solution containing norepinephrine from 0.04 to 0.20 mg / ml, characterized in that it includes the following stages: a. dissolve norepinephrine and optionally an excipient in deoxygenated or degassed water to obtain a norepinephrine concentration of 0.04 to 0.20 mg / ml, b. adjust the pH of the resulting solution by adding hydrochloric acid to reach a value in the range of 3.2 to 3.6, c. filter the resulting norepinephrine solution into a stream of inert gas, d. distribute the norepinephrine solution in a stream of an inert gas, e. sterilize the norepinephrine solution.
Description
Claims (1)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITMI20140306 | 2014-02-27 | ||
| ITMI20140306 | 2014-02-27 | ||
| PCT/EP2015/054021 WO2015128418A1 (en) | 2014-02-27 | 2015-02-26 | Process for producing a stable low concentration, injectable solution of noradrenaline |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2663817T3 true ES2663817T3 (en) | 2018-04-17 |
Family
ID=50693780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES15712064.3T Active ES2663817T3 (en) | 2014-02-27 | 2015-02-26 | Process to produce a stable injectable solution of noradrenaline at low concentration |
Country Status (41)
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UY35988A (en) | 2014-02-27 | 2015-09-30 | Sint Sa | PROCESS FOR THE PRODUCTION OF AN INJECTABLE LOW CONCENTRATION NORADRENALINE SOLUTION |
| EP2990031B1 (en) | 2014-08-28 | 2019-11-13 | Sun Pharmaceutical Industries Ltd | Parenteral dosage form of norepinephrine |
| WO2018140894A1 (en) | 2017-01-30 | 2018-08-02 | Nevakar, Inc | Norepinephrine compositions and methods therefor |
| CN109394683A (en) * | 2018-12-07 | 2019-03-01 | 远大医药（中国）有限公司 | A kind of preparation method of noradrenaline bitartrate injection |
| US10888534B2 (en) | 2019-04-26 | 2021-01-12 | InfoRLife SA | Storage stable ready-to-use norepinephrine aqueous solutions in flexible plastic bags |
| US12097170B2 (en) | 2020-03-06 | 2024-09-24 | Baxter International Inc. | Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation |
| WO2022084775A1 (en) * | 2020-10-21 | 2022-04-28 | Sintetica S.A. | Ready to use, noradrenaline drip bags, having low subvisible particle counts |
| PL4051251T3 (en) * | 2020-10-21 | 2024-04-08 | Sintetica S.A. | Stable, injectable noradrenaline solutions free of antioxidants |
| US11331266B1 (en) * | 2020-10-29 | 2022-05-17 | Medefil, Inc. | Antioxidant free, norepinephrine bitartrate injection in amber glass vials |
| US20220233473A1 (en) * | 2021-01-28 | 2022-07-28 | Cumberland Pharmaceuticals Inc. | Injectable solution of norepinephrine |
| AR124867A1 (en) | 2021-02-15 | 2023-05-10 | Sintetica S A | A DRUG IN A HERMETICALLY SEALED READY-TO-USE FOLDABLE IV DRIP BAG, METHOD OF MAKING SUCH DRUG AND DRUG MADE BY SUCH METHOD |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2809619B1 (en) | 2000-06-06 | 2004-09-24 | Pharmatop | NOVEL AQUEOUS FORMULATIONS OF OXIDATION-SENSITIVE ACTIVE INGREDIENTS AND PROCESS FOR OBTAINING THEM |
| FR2832063B1 (en) * | 2001-11-15 | 2004-08-27 | Aguettant Lab | PROCESS FOR PRODUCING STABLE SOLUTIONS OF PHENOLIC SUBSTANCES AND THE RESULTS THEREOF |
| BR0311965A (en) | 2002-06-20 | 2005-03-29 | Novalar Pharmaceutical Inc | Stabilized formulations of alpha adrenergic receptor antagonists and their uses |
| US20040005401A1 (en) | 2002-07-05 | 2004-01-08 | Robert Becker | Method for applying a washcoat to suppport bodies |
| US7078876B2 (en) | 2003-07-07 | 2006-07-18 | Pentadyne Power Corporation | Feedforward controller for synchronous reluctance machines |
| FR2880807B1 (en) * | 2005-01-19 | 2007-04-13 | Aguettant Sa Lab | PHARMACEUTICAL COMPOSITION INJECTABLE |
| US7465489B2 (en) | 2005-11-15 | 2008-12-16 | Poly-Med, Inc. | Inorganic-organic melted-extruded hybrid filaments and medical applications thereof |
| FR2894154B1 (en) | 2005-12-06 | 2008-03-14 | Pharmatop Scr | NOVEL METHOD FOR STABILIZING OXIDATION - SENSITIVE MINERAL OR ORGANIC SUBSTANCES. |
| EP2096433A1 (en) | 2008-02-26 | 2009-09-02 | Siemens Aktiengesellschaft | Device for non-destructive materials testing of a test specimen with ultrasonic waves |
| US8419689B2 (en) | 2008-09-30 | 2013-04-16 | Covidien Lp | Enclosing package for medical port and cover |
| CN102497882A (en) * | 2009-06-04 | 2012-06-13 | Alk股份公司 | Stabilised composition comprising at least one adrenergic compound |
| US8628805B2 (en) | 2009-06-04 | 2014-01-14 | Alk Ag | Stabilized composition comprising at least one adrenergic compound |
| FR2963237B1 (en) | 2010-07-28 | 2013-05-17 | Aguettant Lab | NOVEL PHARMACEUTICAL COMPOSITION USEFUL FOR PREVENTING OR TREATING PEROPERATIVE ARTERIAL HYPOTENSION IN HUMAN BEINGS |
| CN102525895B (en) | 2012-01-04 | 2013-11-06 | 上海禾丰制药有限公司 | Norepinephrine bitartrate injection and preparation process thereof |
| UY35988A (en) | 2014-02-27 | 2015-09-30 | Sint Sa | PROCESS FOR THE PRODUCTION OF AN INJECTABLE LOW CONCENTRATION NORADRENALINE SOLUTION |
| US20160005871A1 (en) * | 2014-07-04 | 2016-01-07 | Semiconductor Energy Laboratory Co., Ltd. | Semiconductor device |
| WO2018140894A1 (en) | 2017-01-30 | 2018-08-02 | Nevakar, Inc | Norepinephrine compositions and methods therefor |
-
2015
- 2015-02-10 UY UY0001035988A patent/UY35988A/en unknown
- 2015-02-12 JO JOP/2015/0031A patent/JO3552B1/en active
- 2015-02-13 AR ARP150100456A patent/AR101148A1/en not_active Application Discontinuation
- 2015-02-24 TW TW104105762A patent/TWI673065B/en not_active IP Right Cessation
- 2015-02-26 ME MEP-2018-88A patent/ME03004B/en unknown
- 2015-02-26 US US17/006,841 patent/USRE49555E1/en active Active
- 2015-02-26 MA MA39200A patent/MA39200A1/en unknown
- 2015-02-26 KR KR1020167026245A patent/KR102306706B1/en active IP Right Grant
- 2015-02-26 BR BR112016019804-2A patent/BR112016019804B1/en active IP Right Grant
- 2015-02-26 MD MDA20160103A patent/MD4628C1/en not_active IP Right Cessation
- 2015-02-26 DK DK15712064.3T patent/DK3110399T3/en active
- 2015-02-26 ES ES15712064.3T patent/ES2663817T3/en active Active
- 2015-02-26 US US15/118,864 patent/US10251848B2/en not_active Ceased
- 2015-02-26 SI SI201530205T patent/SI3110399T1/en unknown
- 2015-02-26 US US17/006,838 patent/USRE49443E1/en active Active
- 2015-02-26 RS RS20180352A patent/RS57044B1/en unknown
- 2015-02-26 CA CA2940347A patent/CA2940347C/en active Active
- 2015-02-26 LT LTEP15712064.3T patent/LT3110399T/en unknown
- 2015-02-26 CR CR20160420A patent/CR20160420A/en unknown
- 2015-02-26 AU AU2015222150A patent/AU2015222150B2/en active Active
- 2015-02-26 JP JP2016551222A patent/JP6635927B2/en active Active
- 2015-02-26 UA UAA201609379A patent/UA118043C2/en unknown
- 2015-02-26 PL PL15712064T patent/PL3110399T3/en unknown
- 2015-02-26 AP AP2016009467A patent/AP2016009467A0/en unknown
- 2015-02-26 CN CN201580010039.4A patent/CN106061467B/en active Active
- 2015-02-26 PE PE2016001537A patent/PE20161375A1/en unknown
- 2015-02-26 US US17/006,840 patent/USRE49422E1/en active Active
- 2015-02-26 EP EP15712064.3A patent/EP3110399B1/en active Active
- 2015-02-26 PT PT157120643T patent/PT3110399T/en unknown
- 2015-02-26 SG SG11201607094WA patent/SG11201607094WA/en unknown
- 2015-02-26 MX MX2016011148A patent/MX367148B/en active IP Right Grant
- 2015-02-26 HU HUE15712064A patent/HUE038738T2/en unknown
- 2015-02-26 EA EA201691734A patent/EA031444B1/en unknown
- 2015-02-26 WO PCT/EP2015/054021 patent/WO2015128418A1/en active Application Filing
- 2015-02-26 MY MYPI2016703113A patent/MY179942A/en unknown
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2016
- 2016-08-08 EC ECIEPI201665957A patent/ECSP16065957A/en unknown
- 2016-08-12 DO DO2016000210A patent/DOP2016000210A/en unknown
- 2016-08-17 CL CL2016002073A patent/CL2016002073A1/en unknown
- 2016-08-18 NI NI201600118A patent/NI201600118A/en unknown
- 2016-08-25 IL IL247501A patent/IL247501B/en active IP Right Grant
- 2016-08-26 PH PH12016501703A patent/PH12016501703B1/en unknown
- 2016-08-26 SV SV2016005265A patent/SV2016005265A/en unknown
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2018
- 2018-04-04 HR HRP20180541TT patent/HRP20180541T1/en unknown
- 2018-04-05 CY CY20181100385T patent/CY1120125T1/en unknown
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